The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

Device Description

The proposed device is a three-layers, flat-pleated mask. Its size is 17.5 cm x 9.5 cm, and it is available in two types, Ear-loop and Tie-On. Both the ear loop and tie-on masks are available in three barrier levels (Level 1, Level 3) based on ASTM F2100: 2019. The mask body is composed of three layers which is made of PP non-woven cloth. The difference between the three levels mask is the density of middle material. The ear loop or tie strings is used to secure the mask over the users' mouth and face. The nosepiece provides a firm fit over the nose. Ear loops are made of Nylon and spandex, and tie strings are made of PP non-woven cloth. The nose clip is made of Aluminum wire.

AI/ML Overview

The provided text is a 510(k) summary for a Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask. It describes the device, its intended use, and comparative testing against a predicate device (K160269) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

Acceptance Criteria and Device Performance

The device acceptance criteria are based on established standards for medical face masks, primarily ASTM F2100:2019, as well as standards for flammability and biocompatibility (ISO 10993 series). The performance of the proposed device is compared against these criteria and the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive table (Table 2: Summary of Non-clinical Testing) outlining the test methodology, purpose, acceptance criteria, and results for the proposed device, categorized by three levels of performance (Level 1, Level 2, Level 3).

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance (Result)
Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M: 2017)	To evaluate effectiveness against exposure to blood and other body fluids.	Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg	Level 1: Pass at 80mmHgLevel 2: Pass at 120mmHgLevel 3: Pass at 160mmHg
Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017))	To determine the particle filtration efficiency of the test article.	Level 1: ≥95%Level 2: ≥98%Level 3: ≥98%	Pass at 98.2% (Level 1)Pass at 99.3% (Level 2)Pass at 99.6% (Level 3)
Bacterial Filtration Efficiency (BFE) (ASTM F2101: 2019)	To determine the bacterial filtration efficiency of the test article using a biological aerosol of Staphylococcus aureus.	Level 1: ≥95%Level 2: ≥98%Level 3: ≥98%	Pass at 98.9% (Level 1)Pass at 99.4% (Level 2)Pass at 99.6% (Level 3)
Differential Pressure (EN 14683:2019+AC: 2019 Annex C)	To measure the breathability of the mask.	Level 1: <5.0 mmH2O/cm²Level 2: <6.0 mmH2O/cm²Level 3: <6.0 mmH2O/cm²	Pass at 3.6 mmH2O/cm² (Level 1)Pass at 4.0 mmH2O/cm² (Level 2)Pass at 4.6 mmH2O/cm² (Level 3)
Flammability (16 CFR Part 1610)	To assess the flammability of the mask material.	Class 1 (lowest flammability)	Class 1
Cytotoxicity (ISO 10993-5: 2009)	To evaluate the in vitro cytotoxicity of the test sample.	Viability ≥70% of blank; 50% extract of test sample should have at least the same or higher viability than 100% extract.	Viability ≥70% of blank; 50% extract had higher viability than 100% extract. Device was non-cytotoxic.
Sensitization (ISO 10993-10: 2010)	To evaluate the sensitization potential of the test sample for skin irritation.	Non-sensitizing	Device was non-sensitizing.
Irritation (ISO 10993-10: 2010)	To evaluate the irritation potential of the test sample for skin irritation.	Non-irritating	Device was non-irritating.

Study Proving Device Meets Acceptance Criteria

The study performed is a series of non-clinical, laboratory-based physical and biological performance tests.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: "Nonclinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results from three nonconsecutive lots of 32 samples per lots (total of 96 samples) for each level claimed below demonstrated that the proposed device complies with the following standards."
- This means for each of the three levels (Level 1, Level 2, Level 3) of masks, 96 samples were tested. Thus, a total of 96 * 3 = 288 samples were tested across all levels for the performance and biocompatibility tests.
Data Provenance: The document does not explicitly state the country of origin where the tests themselves were conducted, but the sponsor and designated submission correspondent are based in China. The study is retrospective, as it involves testing completed products against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable. For medical face masks, ground truth is established through standardized laboratory testing protocols (e.g., ASTM, EN, ISO standards), rather than expert consensus on individual "cases" or interpretations. The results are quantitative measurements or pass/fail determinations based on predefined acceptance criteria.

4. Adjudication Method for the Test Set:

None. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation (e.g., radiologists reading images) where disagreement or subjective assessment might occur. In this context of laboratory performance testing, the results are objective measurements against set criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC study is not relevant here as the device is a medical face mask, not an AI-powered diagnostic tool, and the evaluation is based on physical and biological performance, not human reader interpretation (with or without AI assistance).

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, by definition, these are standalone tests. The tests performed (fluid resistance, particulate filtration, bacterial filtration, differential pressure, flammability, biocompatibility) are all laboratory tests assessing the intrinsic properties and performance of the mask materials and construction. There is no "human-in-the-loop" component in the testing methodology itself beyond conducting the standardized procedures.

7. The Type of Ground Truth Used:

Standardized Laboratory Test Results and Regulatory Standards/Acceptance Criteria. The ground truth for this device is based on the quantitative and qualitative outcomes of the physical and biological tests as defined by recognized national and international standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility, 16 CFR Part 1610 for flammability). The device "meets acceptance criteria" if its measured performance falls within the specified ranges or passes the qualitative thresholds set by these standards.

8. The Sample Size for the Training Set:

Not Applicable. This device is a manufactured product, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The consistency and quality of the production are assured through manufacturing controls and testing samples from production lots.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant to the described device. The "ground truth" for ensuring the quality of the manufactured product is adherence to the established material specifications, manufacturing processes, and final product testing against the performance standards, validated with samples from production lots.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 19, 2021

Xiantao S&J Protective Products Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K211462

Trade/Device Name: Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 8, 2021 Received: July 15, 2021

Dear Diana Hong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K211462

Device Name Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary – K211462

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K211462

1. Date of Preparation: 08/02/2021
1. Sponsor Identification

Xiantao S&J Protective Products Co., Ltd.

103 Mianyang Road, Xiantao, Hubei, China.

Establishment Registration Number: 3011434305

Contact Person: Dove Wei Position: Marketing Director Tel: +86 18672857899 Fax: +86 728 8877866 Email: wei@sjdisposable.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask Common Name: Surgical Face Mask

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

Indication for use

Device Description:

Identification of Predicate Device રું.
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on)

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Technological Characteristics Comparison 6.

ITEM	Proposed Device			Predicate Device K160269			Comparison
	Disposable Ear-loop Medical Face Mask/Disposable Tie-OnMedical Face Mask			Surgical Face Masks(Ear loops and Tie-on)
	Level 1	Level 2	Level 3	Level 1	Level 2	Level 3
Product Code	FXX			FXX			Same
Regulation No.	21 CFR 878.4040			21 CFR 878.4040			Same
Class	II			II			Same
Indication for Use	The Disposable Ear-loop Medical Face Mask/Disposable Tie-On Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.			The surgical face masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.			Same
				Level 1 Face Mask Models: # EL 10000, EL 10010, TO10000, TO 10010
				Level 2 Face Mask Models: # EL 20000, EL 20010, TO20000, TO 20010
				Level 3 Face Mask Models: # EL 30000, EL 30010, TO30000, TO 30010
Mask style	Flat pleated			Flat pleated			Same
Design feature	Ear-loop / Tie-on			Ear loop / Tie-on			Same
Dimension (mm)	Ear loops: Body: 175 mm×95 mm, nose clip: 125mm,Ear-loop: 175mmTie-on: Body: 175 mm×95 mm, nose clip: 125mm,Tie strings: 910mm			175 mm×90 mm180 mm×90 mm		Analysis 1
ASTM F2100 Level	Level 1	Level 2	Level 3	Level 1	Level 2	Level 3	Same
Fluid resistance	Pass at 80mmHg	Pass at 120mmHg	Pass at 160mmHg	Pass at 80mmHg	Pass at 120mmHg	Pass at 160mmHg	Same
Particulate efficiency level	Pass at 98.2%	Pass at 99.3%	Pass at 99.6%	Pass at 99.6%	Pass at 99.6%	Pass at 99.7%	Analysis 2
Bacterial filtration level	Pass at 98.9%	Pass at 99.4%	Pass at 99.6%	Pass at >98%	Pass at >98%	Pass at >99%	Analysis 3
Differential pressure	Pass at 3.6 mmH2O/cm²	Pass at 4.0 mmH2O/cm²	Pass at 4.6 mmH2O/cm²	Passed at 2.0 mmH2O/cm²	Passed at 1.6 mmH2O/cm²	Passed at 2.5 mmH2O/cm²	Analysis 4
Flammability	Class 1			Class 1			Same
Label/Labeling	Complied with 21 CFR part 801			Complied with 21 CFR part 801			Same
Materials
Outer layer Material	23g/m² PP non-woven cloth			Polypropylene			Analysis 5
Inner layer Material	20g/m² PP non-woven cloth			Polypropylene
Middle layer Material	22g/m² PP non-woven cloth	25g/m² PP non-woven cloth	33g/m² PP non-woven cloth	1. Polypropylene spunbond2. Polypropylene melt blown
Nose Clip	Aluminum wire			Polyethylene coated steel wire
Ear-Loop	Nylon and Spandex			Polyester, Polyurethane, Side tapes: Polyester spunbond(ear loops mask only)
Tie strings	35 g/m² PP non-woven cloth			Polypropylene spunbond or Polyester spunbond
Colors	Blue			Blue and white			Analysis 6

Table 1 General Comparison

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Biocompatibility
Cytotoxicity	Under the conditions of the study, the proposed device wasnon-cytotoxic.	Under the conditions of the study, the subject device wasnon-cytotoxic.	Same
Sensitization	Under the conditions of the study, the proposed device wasnon-sensitizing.	Under the conditions of the study, the subject device wasnon-sensitizing.	Same
Irritation	Under the conditions of the study, the proposed device wasnon-irritating.	Under the conditions of the study, the subject device wasnon-irritating.	Same
Sterility	Non-Sterile	Non-Sterile	Same

Analysis 1 - Dimension (mm)

The dimension for the proposed device is different from predicate device.

Analysis 2 - Particulate efficiency level

The test result of particulation efficiency for the proposed device. However, the test result of the proposed devices can meet the requirements of level 1/level 2/level 3 based on ASTM F2100-19.

Analysis 3 - Bacterial filtration level

The test result of bacteria filtration efficiency for the proposed device is different from predicate device.

Analysis 4 - Differential pressure

The test result and reference standard of different in the proposed device is different from predicate device can med the requirents of the standard ASTM F2100: 2019 which was recognized by FDA.

Analysis 5 - Materials

The material for the proposed device is different from producted to the been performed on the proosed device and the results does not show any adverse effect.

Analysis 6 - Color

The proposed device is blue, and the provided in two colors, the color of the proposed device can be covered by the predicate device.

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7. Summary of Non-Clinical Test

Nonclinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results from three nonconsecutive lots of 32 samples per lots (total of 96 samples) for each level claimed below demonstrated that the proposed device complies with the following standards:

ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
ASTM F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

Test Methodology	Purpose	Acceptance Criteria	Result
Resistance to Penetrationby Synthetic blood	The test was performed inaccordance with ASTMF1862/F1862M: 2017Standard Test Method forResistance of MedicalFace Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity) to evaluate theeffectiveness of the testsample from possibleexposure to blood andother body fluids.	Level 1: No penetration at80 mmHg	Level 1: Pass at 80mmHg
		Level 2: No penetration at120 mmHg	Level 2: Pass at120mmHg
		Level 3: No penetration at160 mmHg	Level 3: Pass at160mmHg
Particulate FiltrationEfficiency	The test was performed inaccordance with ASTMF2299/F2299M-03 (2017)Standard Test Method forDetermining the InitialEfficiency of MaterialUsed in medical FaceMasks to Penetration byParticulates using LatexSpheres to determine theparticle filtrationefficiency (PFE) of thetest article.	Level 1: ≥95%	Pass at 98.2%
		Level 2: ≥98%	Pass at 99.3%
		Level 3: ≥98%	Pass at 99.6%
	The test was performed inaccordance with ASTMF2101: 2019 StandardTest Method forEvaluating the BacterialFiltration Efficiency(BFE) of Medical FaceMask Materials, Using aBiological Aerosol ofStaphylococcus aureus todetermine the bacterialfiltration efficiency (BFE)of the test article.	Level 1: ≥95%	Pass at 98.9%
Bacterial FiltrationEfficiency		Level 2: ≥98%	Pass at 99.4%
		Level 3: ≥98%	Pass at 99.6%

Differential Pressure	The test was performed inaccordance with EN14683:2019+AC: 2019Annex C Medical facemasks - Requirementsand test methods.	$<5.0 \text{ mmH}_2\text{O/cm}^2$	Pass at $3.6 \text{ mmH}_2\text{O/cm}^2$
		$<6.0 \text{ mmH}_2\text{O/cm}^2$	Pass at $4.0 \text{ mmH}_2\text{O/cm}^2$
		$<6.0 \text{ mmH}_2\text{O/cm}^2$	Pass at $4.6 \text{ mmH}_2\text{O/cm}^2$
Flammability	The test was performed inaccordance with 16 CFRPart 1610 Standard for theFlammability of ClothingTextiles.	Class 1	Class 1
Cytotoxicity	The test was performed inaccordance with ISO10993-5 Third edition2009-06-01 Biologicalevaluation of medicaldevices - Part 5: Tests forin vitro cytotoxicity toevaluate the cytotoxicityof the test sample.	The viability should be≥70% of the blank. Andthe 50% extract of the testsample should have atleast the same or a higherviability than the 100%extract.	The viability was ≥70%of the blank. And the 50%extract of the test samplehad a higher viability thanthe 100% extract.Under the conditions ofthe study, the proposeddevice was non-cytotoxic.
Sensitization	The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization to evaluatethe sensitization of thetest sample.	Non-sensitizing	Under the conditions ofthe study, the proposeddevice was non-sensitizing.
Irritation	The test was performed inaccordance with ISO10993-10 Third Edition2010-08-01 Biologicalevaluation of medicaldevices - Part 10: Testsfor irritation and skinsensitization to evaluatethe irritation of the testsample.	Non-irritating	Under the conditions ofthe study, the proposeddevice was non-irritating.

Table 2 Summary of Non-clinical Testing

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1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Conclusion
  The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K160269.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.